GXP Solutions | Newsletter

What FDA’s 2025 Warning Letters Reveal About Current GMP Compliance Risks

FDA’s 2025 warning letters are out — and they send a very clear message: the agency is back in force on GMP enforcement, and the fundamentals are where firms continue to stumble. Whether your operations are sterile or non-sterile, API or finished dose, the issues that keep showing up are not random — they point […]

January 15, 2026

Verifying CRO Compliance With SUSAR Reporting Timelines and Determination of Expedited vs. Standard Reporting

Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the highest regulatory risk areas in clinical development. Health Authorities (HAs) globally, including the FDA, EMA, and national competent authorities, impose strict timelines and documentation expectations for SUSAR identification, assessment, and reporting. Sponsors frequently delegate pharmacovigilance (PV) case processing and regulatory reporting activities to Contract Research […]

January 15, 2026

Understanding 21 CFR Part 11 Compliance

Ensuring compliance with 21 CFR Part 11 helps maintain the integrity, reliability, and security of electronic records and signatures, which are critical for regulatory approval and inspection readiness. When evaluating your electronic systems for 21 CFR Part 11 compliance, the focus should be on assessing the systems and processes related to electronic records and electronic […]

November 18, 2024

How to Audit a RABS (Restricted Access Barrier Systems) isolators for GMP

How to Audit a RABS (Restricted Access Barrier Systems) isolators for GMP (Good Manufacturing Practices) involves thorough assessment to ensure compliance with regulatory requirements and industry standards. Here’s a structured approach you can follow: Pre-Audit Preparation Review Documentation: Obtain and review relevant SOPs (Standard Operating Procedures), validation documents, maintenance records, and any previous audit reports […]

June 16, 2024